Crit-Line® - Blood Volume Monitor - Fresenius Usa, Inc.

Duns Number:076594100

Device Description: Blood Volume Monitor

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More Product Details

Catalog Number

-

Brand Name

Crit-Line®

Version/Model Number

CL10051001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141997

Product Code Details

Product Code

KOC

Product Code Name

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Device Record Status

Public Device Record Key

a5bfa337-76f7-4a5d-a0ee-d6b50aa35ac2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FRESENIUS USA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27